HD 380 Valipak

SAFETY GUARANTEED: VALIDATION OF HEAT SEALING PROCESSES.The safety of doctor and patient is at the forefront of all considerations. Primary objective of packing critical medical devices (instruments which penetrate the skin or mucous membrane and thus come into contact with blood, internal tissues or organs, including wounds) in medical and dental practices is the maintenance of sterility until the point of use.The international standards ISO 11607-2 and ANSI/AAMI/ISO 11607-2 therefore explicitly call for validated processes for packing medical devices.Sealing devices must meet the following validation requirements:> monitoring of critical process parameters and> warn the user in case of deviation from preset valuesAs the first heat sealer in its class the ValiPak® meets these requirements.Three high-tech sensors monitor the critical process parameters(temperature, sealing time and sealing pressure) during thesealing process. If one of the parameters deviates, the user is notified acoustically and visibly via the display. Furthermore, the device has a PC interface (for process and batch documentation systems). Another safety feature is the extra wide seal seam width.

RANGE OF USE AND CERTIFICATIONSEspecially suitable for use in Medical and dental practicesCE sign xConformity ISO 11607-2 and ANSI/AAMI/ISO 11607-2 xCalibration certificate xGreenTek® x